Recruitment Of Study Participants Research Articles

Abstract PO3-09-09: Interventions to improve adherence to oral endocrine therapy for prevention or treatment of breast cancer in African American women of low socioeconomic status

Abstract Introduction: Adherence to oral endocrine therapy (OET) for the prevention and treatment of hormone receptor-positive breast cancer (BC) is important as they reduce the risk of new or recurrent BC. OET adherence is greatly compromised in women of lower socioeconomic status (SES). We have recently reported that patients belonging to the African American race, with longer time on OET, and using OET in the prevention setting are more likely to be non-adherent to OET. Therefore, our study aims to design unique patient-centered interventions and pilot test their feasibility, acceptability, and effectiveness in improving OET adherence in African American women of low SES. Patients and Methods: This prospective study includes adult, African American women on OET for either the prevention or treatment of BC at Harris Health System in Houston, Texas, serving the underserved patient population with low SES. The first intervention is a motivational interviewing (MI) based telephone intervention consisting of an initial phone call followed by five monthly follow-up calls with an MI-trained pharmacy student. The second intervention is a theatre-based educational video with a script developed by a local African American playwright, featuring African American women. Three African American BC survivors with experience in taking OET consulted with the study team to convey their BC journey and explain challenges with taking OET. They provided feedback on the script and production of the educational video. Informed consent was obtained verbally via phone in the MI intervention and electronically for the educational video intervention. Individuals in both intervention groups were compensated with Walmart eGift cards. Pre- and post-intervention adherence was measured using the proportion of days covered (PDC) over 6-12 months and compared using a paired t-test. Participants also complete a survey at the end of the interventions to determine their acceptability. The survey responses were summarized descriptively. Results: For the MI intervention initiated in 20 patients, the median age and BMI of study participants was 61 years (range: 49-71) and 30.8 (range: 22.3-57.8) respectively. All participants identified their ethnicity as non-Hispanic or Latino. The majority of participants had hypertension (n=13, 65%) and/or hyperlipidemia (n=11, 55%) with depression (n=3, 15%) and diabetes (n=8, 40%) being less common. The most common stage of BC cancer was stage I (n=9, 45%), followed by stage II (n=4, 20%), stage 0 (n=3, 15%) and then stage III (n=2, 10%) and IV (n=2, 10%). Letrozole was the most common OET (n=13, 65%), followed by tamoxifen (n=3, 15%), anastrozole (n=2, 10%) and exemestane (n=2, 10%). Most participants were not on a CDK 4/6 inhibitor (n=18, 90%). The median number of years on therapy was 2.8 (0.6-4.5). The median pre-intervention PDC for OET was 0.7 (range: 0.2-0.9). The MI intervention is expected to be complete by October 2023 for all patients. For the educational video intervention, 7 out of the anticipated 25 participants have been enrolled in the intervention. All patients were taking OET for BC treatment and not prevention. Letrozole (n=3, 43%) and anastrozole (n=3, 43%) were the most utilized OET, followed by exemestane (n=1, 14%). While 5 participants (71%) in this intervention reported not missing any OET doses in the past week, 2 patients (29%) reported missing all 7 doses within the past week. After watching the educational video, most participants (n=6, 86%) reported that they strongly agreed to take their OET regularly. The recruitment of study participants for this intervention is ongoing. Conclusion: In this study, we report that MI and educational video interventions are feasible. The interventions and analysis of their effectiveness and acceptability are ongoing. Citation Format: Camille Johnson, Ann Adigwe, Nicole Ekezie, Bilqees Fatima, Zahra Majd, Keith Houk, Tejal Patel, Rob Shimko, Onyebuchi Ononogbu, Susan Abughosh, Meghana Trivedi. Interventions to improve adherence to oral endocrine therapy for prevention or treatment of breast cancer in African American women of low socioeconomic status [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-09-09.

Selecting a randomization method for a multi-center clinical trial with stochastic recruitment considerations

BackgroundThe design of a multi-center randomized controlled trial (RCT) involves multiple considerations, such as the choice of the sample size, the number of centers and their geographic location, the strategy for recruitment of study participants, amongst others. There are plenty of methods to sequentially randomize patients in a multi-center RCT, with or without considering stratification factors. The goal of this paper is to perform a systematic assessment of such randomization methods for a multi-center 1:1 RCT assuming a competitive policy for the patient recruitment process.MethodsWe considered a Poisson-gamma model for the patient recruitment process with a uniform distribution of center activation times. We investigated 16 randomization methods (4 unstratified, 4 region-stratified, 4 center-stratified, 3 dynamic balancing randomization (DBR), and a complete randomization design) to sequentially randomize n=500\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$n=500$$\\end{document} patients. Statistical properties of the recruitment process and the randomization procedures were assessed using Monte Carlo simulations. The operating characteristics included time to complete recruitment, number of centers that recruited a given number of patients, several measures of treatment imbalance and estimation efficiency under a linear model for the response, the expected proportions of correct guesses under two different guessing strategies, and the expected proportion of deterministic assignments in the allocation sequence.ResultsMaximum tolerated imbalance (MTI) randomization methods such as big stick design, Ehrenfest urn design, and block urn design result in a better balance–randomness tradeoff than the conventional permuted block design (PBD) with or without stratification. Unstratified randomization, region-stratified randomization, and center-stratified randomization provide control of imbalance at a chosen level (trial, region, or center) but may fail to achieve balance at the other two levels. By contrast, DBR does a very good job controlling imbalance at all 3 levels while maintaining the randomized nature of treatment allocation. Adding more centers into the study helps accelerate the recruitment process but at the expense of increasing the number of centers that recruit very few (or no) patients—which may increase center-level imbalances for center-stratified and DBR procedures. Increasing the block size or the MTI threshold(s) may help obtain designs with improved randomness–balance tradeoff.ConclusionsThe choice of a randomization method is an important component of planning a multi-center RCT. Dynamic balancing randomization with carefully chosen MTI thresholds could be a very good strategy for trials with the competitive policy for patient recruitment.

Health-related physical fitness, physical activity and its correlates among school going adolescents in hilly state in north India: a cross sectional survey

IntroductionHealth-related physical fitness, which includes body composition, cardiorespiratory fitness, muscular endurance, flexibility, power, and strength are associated with risks of chronic diseases and promote good health and wellness. There have been reports of increasing levels of physical inactivity among children and adolescents, leading to increasing rates of obesity and decreased physical fitness. The present study was conducted among school going adolescents to estimate the levels and correlates of PF for timely intervention.MethodologySchool based cross-sectional study was done among students of class 8-11th in Government schools of Garhwal division of Uttarakhand. Multistage stratified random sampling was applied for recruitment of study participants. We recruited a final sample size of 634 students. Validated questionnaires and standard methods for assessment of physical fitness, physical activity levels and other variables such as waist circumference, hip circumference, BMI and hemoglobin estimation were done.ResultsAverage and above average cardiorespiratory fitness score as per Harvard step test among boys (54.3%) was significantly higher as compared to girls (21.3%) (χ2 = 88.93, p < 0.001). There was a significant association between gender and dominant handgrip strength (χ2 = 8.02, p = 0.01) as well as between gender and Shoulder stretch test (SST) of dominant (χ2 = 17.5, p < 0.05) as well as nondominant arm (χ2 = 13.5, p < 0.05). Sit and reach test results also showed a significant association with gender (χ2 = 27.17, p < 0.001). Gender, hemoglobin level, BMI and PAL scores significantly predicted cardiorespiratory fitness scores (R2 = 0.188, F value of the model = 37.69, p =< 0.001)).ConclusionPhysical fitness of school going adolescents in Garhwal division of Uttarakhand was better than other parts of India, with significant gender differences. Physical activity levels (PAL) were poor and are also a significant predictor of physical fitness. More emphasis needs to be paid on the health and fitness of girl students. School based policies to increase PAL among students through innovation and rewards may go a long way in improving the long-term health of the students.

Creating a patient reported outcome measure for medication-related quality of life: a concept mapping brainstorming study in Ontario, Canada

Introduction: Persons with mobility limitations generally take multiple medications to manage their conditions; however, healthcare providers across different settings do not currently have a way to measure the impact that medication taking has on patients’ quality of life (QoL). Current tools are limited, narrowly focused on few QoL domains and none focus on persons with mobility limitations. &#x0D; Target Audience: The target audience for our study findings are healthcare providers working with individuals with mobility limitations across different healthcare settings. &#x0D; Who was involved: This study included patient and caregiver partners. They were involved in the grant application, study participant recruitment, data collection, and final data analysis. This study also involved healthcare providers who supported participant recruitment and will be knowledge users, including pharmacists, physicians, and physical therapists. &#x0D; Aims and Methods: The aim of this study was to identify a list of potential items for the creation of a patient reported outcome measure (PROM) from the perspectives of individuals with mobility limitations who take medications. We used a mixed methods concept mapping approach to gather perspectives from across Canada. Here, we report on the results of the qualitative brainstorming phase of the study. Participants created a list of statements reflecting what matters to them about their medications in their everyday life. The statements were de-duplicated and condensed, following which, they were thematically analyzed and mapped onto common quality of life domains. &#x0D; Results: Twenty-two persons with mobility limitations across Canada participated in this study. Six hundred and ninety-four statements were condensed into 80 final statements. The final statements mapped onto common quality of life domains (physical health; mental health; employment/social/leisure activities; daily activities; interactions with providers; navigating the healthcare system; autonomy and decision-making; financial health) indicating a comprehensive list of items for the creation of the PROM. In addition, we identified some mobility limitation specific concepts relating to barriers to physically accessing medications and necessary testing, and to perceived health plan or policy restrictions.&#x0D; Learnings for the international audience: Results from this study emphasized the importance of including patient autonomy, decision-making and financial concerns, which are often excluded from other measures related to medication taking and QoL. Additionally, we identified other topics that matter to individuals such as impact on lifestyle activities, patient self-management, ease of access to medications and necessary testing, as well as financial challenges associated with medication taking. &#x0D; Next Steps: The next phases of concept mapping will be conducted, which will identify statements that are important and realistic to individuals with mobility limitations and a final conceptual mapping session. Statements that are rated highly on both scales will inform the development of items for the PROM, which will be validated in future work. In developing and validating a PROM for medication-related QoL, we aim to provide clinicians with an invaluable tool to enhance and monitor clinical care and patient outcomes. We envision this PROM might be used to inform overall medication management.

Concept mapping brainstorming results for improving care transitions for adults with hip fracture in Ontario, Canada

Introduction: Individuals who have experienced a hip fracture often undergo numerous transitions in care between providers and sectors. These transitions are a time of vulnerability with the potential for poor health outcomes and experiences, yet there are limited recommendations on how to improve this care journey for adults with hip fracture.&#x0D; Target Audience: The target audience for our study include decision-makers and providers with a hip fracture portfolio, as well as patients who have experienced a hip fracture and their unpaid caregivers. &#x0D; Who was involved: This study included patient and caregiver partners. They were involved in the grant application, study participant recruitment, data collection, and final data analysis. This study also included healthcare provider and decision-maker partners who supported participant recruitment and will be knowledge users. &#x0D; Aims and Methods: The aim of this study was to create a list of actionable recommendations to improve care transitions for individuals with hip fracture from the perspectives of patients, caregivers, providers, and decision-makers. We used a mixed methods concept mapping approach, to gather perspectives from these key stakeholders in Ontario, Canada. Here, we report on the results of the first phase of the concept mapping study. Participants created a list of statements that they felt would improve care transitions for individuals who had experienced a hip fracture. The statements were analyzed inductively and grouped thematically. &#x0D; Results: Thirty-two individuals participated in the brainstorming phase of this study (2 patients, 5 caregivers, 21 providers, 4 decision-makers). They created 887 statements that were condensed by the research team into 72 final statements. The final statements were grouped into seven main themes and were divided into four domains for care transition improvement. The first is the patient-related domain, which encompassed two themes: self-management and self-management-support, and rehabilitation therapy and activities. The second domain is provider-related and includes: healthcare provider skills and communication and trust. The third domain includes two system-related themes: continuity of care and health system efficiencies. The last domain relates to care processes with one theme: transition planning and follow up care. &#x0D; Learnings for the international audience: Previous literature on improving care transitions has had focused primarily on the transfer of information between care providers with little emphasis on the caregiver/patient role. Our results, however, highlight the importance of meaningful patient and caregiver engagement, with active involvement in all aspects of care including the transition process. Further, many statements created by our participants included policies, assessments, and care specific to individuals with hip fracture and cognitive impairment/delirium, emphasizing this as an important area for consideration when aiming to improve care transitions. &#x0D; Next Steps: The next phases of concept mapping will be conducted, which will include statement sorting and rating (importance and priority). A final concept mapping session will be held integrating the qualitative and quantitative data and an opportunity to reflect on the findings with key stakeholders. Statements that are rated highly importance and priority will inform actionable recommendations to improve care transitions for hip fracture.

Participant recruitment among vulnerable populations: An experience from a qualitative study among refugee adolescents in Germany.

When it comes to actual practice, comparing to theoretical plans, the study progress is much more complicated due to both predicted and unpredicted challenges in the study participant recruitment. The situation is even more difficult if the research team deal with a vulnerable population. The current article represents and discusses the recruitment process for a currently unpublished qualitative study, conducted in Germany in 2021, as the first phase of our project: SC-SD4ASA: A self-care/self-development guidebook for asylum-seeking adolescents. First a brief of the study methodology is outlined and then, the strategies used to reach the potential participants including major/government organizations for refugees, private organizations and local centers, social media, youth's favorite public places, and participatory strategy are discussed. Finally, our experience of participant recruitment challenges in this study is reviewed. We hope that the points raised from our experience can be helpful to other researchers in the same field. Overall, the experience of recruiting our participants emphasized the necessity for a dedicated point of contact for consultation and the provision of resources to connect with potential participants for researchers in the field of refugee and migrant health. Furthermore, the influence of trustworthy individuals, particularly within the community, should not be underestimated. Their assistance can significantly benefit the advancement of a research project.

Merits and Pitfalls of Social Media as a Platform for Recruitment of Study Participants.

Efficient and effective methods of recruiting participants for studies have characteristically come with many challenges. The unprecedented rise of social media platforms such as Facebook and Instagram has revolutionized the ease of recruiting participants as compared to more traditional methods such as newspaper or radio advertisements. While these new advancements may seem to increase the success of recruitment, they are not without their own faults and limitations. In this paper, we intend to dissect the advantages and disadvantages of social media platforms in recruiting participants. Specifically, we will discuss the advantages of targeted and rapid recruitment, engagement, and cost reduction as well as the disadvantages of representativeness, privacy concerns, limited control, and limited access.

Effects of a Community Health Worker-Led Health Literacy Intervention on Lifestyle Modification Among Patients With Hypertension and Diabetes in the City of Harare, Zimbabwe: Protocol for a Cluster Randomized Controlled Trial.

Hypertension and diabetes are among the most common noncommunicable diseases in Zimbabwe. These 2 conditions are largely prevented and controlled by lifestyle modifications, such as healthy eating habits, physical activity, and avoiding the use of tobacco and alcohol. This study aims to evaluate the effects of a community health worker (CHW)-led health literacy intervention on lifestyle modification among patients with diabetes and hypertension in the City of Harare, Zimbabwe, in terms of (1) adherence to recommended lifestyle changes, (2) blood pressure and blood glucose levels, and (3) medication adherence. This is a 6-month-long cluster randomized controlled trial, which will be conducted in primary health care clinics in the city of Harare. A total of 14 clinics will be randomly allocated into either the intervention or control group. A total of 680 (49 participants per clinic) adult patients with hypertension and diabetes will be enrolled for the trial. Participants in the intervention arm will receive a simple health literacy intervention on lifestyle modification, which will be delivered by trained CHWs, while those in the control arm will receive usual care. The intervention consists of 4 face-to-face interactive educational sessions and monthly support visits by trained CHWs and will be carried out over a period of 6 months. The primary study outcomes will be blood pressure and blood glucose levels and levels of adherence to the recommended lifestyle modifications. Other outcomes will include adherence to medication. Data management and analysis will be done using Epi Info software, and the data will be analyzed using the intention-to-treat principle. Recruitment of study participants commenced on June 1, 2023, and was completed on July 30, 2023. Baseline data are being collected after participants' recruitment, and the final data collection will be completed by January 31, 2024. There is an information dearth regarding the effectiveness of CHW-led interventions for the management and control of hypertension in Zimbabwe. Our study offers an opportunity to show the effectiveness of CHWs in addressing the gaps in the management of hypertension and diabetes. The findings from our study will provide crucial evidence on the effectiveness and feasibility of a simple intervention delivered by CHWs in resource-constrained areas. PRR1-10.2196/47512.

Improving bereavement outcomes in Zimbabwe: results of a feasibility cluster trial of the 9-cell bereavement tool

ContextDespite high mortality rates from both communicable and non-communicable diseases, bereavement is under-researched in African countries. The 9-cell bereavement tool was designed to assist individuals to reflect on their feelings about bereavement and identify resources in families and communities to manage bereavement. This study aimed to determine the feasibility of implementing the 9-cell bereavement tool and recruitment to experimental evaluation.MethodsA feasibility cluster randomized trial with embedded qualitative interviews was conducted in two comparable neighbourhoods in Chitungwiza, Zimbabwe. Community leaders identified potential community lay bereavement supporters (interventionists). Each community lay bereavement supporter recruited two to three recently bereaved community members (trial participants). Following baseline data collection, the communities were randomly allocated to intervention or wait-list control. Self-administered questionnaires were completed at T0 (month 0), T1 (3 months) and T2 (6 months). Grief, mental health and social support were assessed. Focus group discussions with selected interventionists described training impact and intervention processes. Quantitative and qualitative analyses were performed.ResultsImplementation of the nine-cell bereavement tool and recruitment to experimental evaluation were successful. Implementation of the tool and the recruitment of study participants were conducted within the intended timeframe of 3 weeks. In line with the suggested sample size, the study was able to recruit and retain at least 75% of the trial participants for the total duration of the study.ConclusionThe feasibility cluster trial was successfully implemented and assessed. Through the published protocol, the literature review and the results of this study, it has been noted that there is an urgent need to carry out a full trial in this subject matter, not only as a contribution to the currently sparse literature in this regard, but for the enormous potential public health benefit in supporting and saving lives in many more under-resourced and under-supported countries.Trial registrationProtocol registration: http://www.isrctn.com/ISRCTN16484746.Protocol publication: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0450-5

Social audio as a tool for public health interventions

There is a constant need for new approaches and technologies to help with public health study participant recruitment, retainment, and interventions. For approximately 15 years, social media text and image/video platforms (e.g., Facebook, and more recently, Instagram, Snapchat, and TikTok), have been increasingly used to assist with these issues in research. However, a new social media format based on audio interactions (i.e., social audio) is gaining popularity and may have advantages over traditional social media platforms. This paper explores how social audio might be used in public health interventions and how they differ from traditional text- and image/video-based social media platforms.

“Everyone needs a Deb”: what Australian indigenous women say about breast cancer screening and treatment services

BackgroundBreast cancer continues to be the second most diagnosed cancer overall and the most diagnosed cancer for women in Australia. While mortality rates overall have declined in recent years, Indigenous women continue to be diagnosed at more marginal rates (0.9 times) and are more likely to die (1.2 times). The literature provides a myriad of reasons for this; however, the voices of Indigenous women are largely absent. This study sets out to understand what is happening from the perspectives of Australian Indigenous women with a view to charting culturally safer pathways that improve participation in screening and treatment by Indigenous women.MethodsThis co-design study was conducted using semi-structured, in-depth interviews and focus group discussions. Recruitment of study participants was via snowball sampling. Participants were subsequently consented into the study through the Aboriginal Health Service and the research team. Interviews were audio recorded and transcribed verbatim, and data coded in NVivo12 using inductive thematic analysis.ResultsA total of 21 Indigenous women and 14 health service providers were interviewed predominantly from the same regional/rural area in NSW, with a small proportion from other states in Australia. Six major themes were identified: Access, Awareness, Community and Family, Lack of control, Negative feelings and associations and Role of services.ConclusionTo improve access and participation of Indigenous women and ultimately improve mortality rates, breast cancer services must explicitly address cultural and community needs.

FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation.

The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning the identification of appropriate data and metadata to be gathered, along with established procedures for their collection, documentation, and management. Furthermore, suitable approaches must be implemented to evaluate and ensure the quality of the data. Therefore, the 'Europe Regional Chapter of the International Society of Exposure Science' (ISES Europe) human biomonitoring working group (ISES Europe HBM WG) proposes the development of a FAIR Environment and health registry (FAIREHR) (hereafter FAIREHR). FAIR Environment and health registry offers preregistration of studies on exposure sciences and environmental epidemiology using HBM (as a starting point) across all areas of environmental and occupational health globally. The registry is proposed to receive a dedicated web-based interface, to be electronically searchable and to be available to all relevant data providers, users and stakeholders. Planned Human biomonitoring studies would ideally be registered before formal recruitment of study participants. The resulting FAIREHR would contain public records of metadata such as study design, data management, an audit trail of major changes to planned methods, details of when the study will be completed, and links to resulting publications and data repositories when provided by the authors. The FAIREHR would function as an integrated platform designed to cater to the needs of scientists, companies, publishers, and policymakers by providing user-friendly features. The implementation of FAIREHR is expected to yield significant benefits in terms of enabling more effective utilization of human biomonitoring (HBM) data.

Remuneration and Recruitment of Study Participants for AD Cohort Studies From the General Public and From Minority Communities.

Offering remuneration for participation in studies of aging and Alzheimer Disease (AD) may improve recruitment, particularly among minoritized and low-income groups. But remuneration may also raise ethical problems and reduce altruistic motivations for participation. A nationally representative sample of Americans (N=2030) with large (N=500) Black and Hispanic oversamples was asked about willingness to participate in a longitudinal AD cohort study after random assignment of remuneration ($0, $50/visit, $100/visit). Respondents were then asked about their perceived burden, risks, and societal contribution from participation. An offer of remuneration increased willingness to participate, with no difference between $50 and $100. The increase was similar across racial, ethnic, and income groups. Remuneration did not affect perceived risks or altruistic benefits. Compensation caused Whites and Hispanics, but not Blacks, to lower the perceived burden. Modest levels of remuneration are likely to improve recruitment to AD research studies without causing collateral ethical or motivation problems. Remuneration does not differentially enhance minority recruitment.

Challenges and opportunities faced by nurse scientists in integrating data and technology in research to promote health equity

Advances in technologies including omics, apps, imaging, sensors, and big data are increasingly being integrated into research by nurse scientists, but the impact on improving health equity is still unclear. In this article, nursing research faculty from one institution discuss challenges and opportunities experienced when integrating various technologies into their research aimed at promoting health equity. Using exemplars from faculty experiences, a three-pronged approach to keeping patients and communities and the goal of health equity central in research while incorporating advancing technologies is described. This approach includes establishing long-term engagement with populations underrepresented in research, adopting strategies to increase diversity in study participant recruitment, and training and collaboration among a diverse workforce of educators, clinicians, and researchers. Training nurse scientists in integrating data and technology for advancing the science on health equity will shift the culture of how we understand, collaborate, and grow with the communities in which we train and practice as nurse scientists.

Outcome Measurement and Evaluation as a Routine practice in alcohol and other drug services in Belgium (OMER-BE)

IntroductionThere is a variety of specialized outpatient and residential Alcohol and Other Drugs (AOD) services, but research on outcomes of these services is limited. Given the chronic, relapsing nature of AOD problems, there is a need for longitudinal research on outcomes after treatment in various AOD services.Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) are hardly used in the AOD field but provide excellent tools and a framework to monitor progress and outcomes in these services based on experiences of service users.ObjectivesThe objectives of the OMER-BE study are to:1. Assess and compare patient characteristics at baseline in various treatment modalities2. Test and prepare the routine measurement of PROMs and PREMs in AOD services using a self-report tool3. Assess patient-reported experiences qualitatively in various treatment modalities for AOD patientsThe overall goal is to continuously assess and improve AOD services.MethodsWe have set up a naturalistic, longitudinal cohort study for which we will engage and follow up 250 AOD users as they present themselves in selected AOD services in four different treatment modalities (outpatient non-pharmacological treatment, outpatient substitution treatment, residential psychiatric treatment and therapeutic communities for addictions).Sociodemographic and clinical factors and PROMs will be assessed at baseline. PROMs and PREMs will be assessed at 45-, 90- and 180-days follow-up. The questionnaires that will be used during the baseline and follow-up assessments are based on the ICHOM Standard Set for Addictions (ICHOM SSA, 2020), a set of brief validated questionnaires to measure and monitor treatment outcomes routinely in AOD services. Following the 6-month follow-up we will perform a qualitative study in a subset of N=20 participants (5 per treatment modality). These participants will be invited to take part in an in-depth interview with one of the researchers, where the following topics will be discussed: treatment history, recovery experiences, helping and hindering factors in recovery, and experiences with different treatment modalities.Results47 participants have been recruited in the OMER-BE study up until October 2022. 38 (81%) of the participants were born male, 9 (19%) were born female. The average age of participants is 33, with ages ranging from 19 to 47 years old.Preliminary findings will be presented at the congress.Further recruitment of study participants up to a total of 250 will be undertaken until the end of 2023.ConclusionsThe OMER-BE study aims to assess and improve AOD services by using a self-report tool, measuring PROMs and PREMs.Disclosure of InterestNone Declared

Adopting Triangulation as an Attempt to Square the Circle: Swipe up for More

Using reflections on research conducted on the speech communities of Esperanto and Emilian, this article focuses on methods of data collection and participant recruitment in studies on minoritized languages whose vitality partly depends on the attitudes and ideologies embodied in the community. The article is divided into two self-contained yet closely related sections. In the first part, a model for triangulation as a methodological framework for language attitude research is outlined as a theoretical contribution to the toolbox of methodologies used in the field. The model proposes a research design that includes a qualitative/quantitative method at the micro level, a qualitative/quantitative method at the meso level, and an ethnographic dimension at the individual, subjective level. The second part of the article is a discussion of the practical and theoretical implications of using Instagram and its Story function as strategies for participant recruitment, dissemination, and data collection when travelling and fieldwork are not possible, such as during the period of Covid-19. The social media platform is here presented as an opportunity to reach younger generations and therefore as apt for data collection for studies interested in language attitudes.

An mHealth Intervention to Reduce Gestational Obesity (mami-educ): Protocol for a Randomized Controlled Trial.

The World Federation of Obesity warns that the main health problem of the next decade will be childhood obesity. It is known that factors such as gestational obesity produce profound effects on fetal programming and are strong predictors of overweight and obesity in children. Therefore, establishing healthy eating behaviors during pregnancy is the key to the primary prevention of the intergenerational transmission of obesity. Mobile health (mHealth) programs are potentially more effective than face-to-face interventions, especially during a public health emergency such as the COVID-19 outbreak. This study aims to evaluate the effectiveness of an mHealth intervention to reduce excessive weight gain in pregnant women who attend family health care centers. The design of the intervention corresponds to a classic randomized clinical trial. The participants are pregnant women in the first trimester of pregnancy who live in urban and semiurban areas. Before starting the intervention, a survey will be applied to identify the barriers and facilitators perceived by pregnant women to adopt healthy eating behaviors. The dietary intake will be estimated in the same way. The intervention will last for 12 weeks and consists of sending messages through a multimedia messaging service with food education, addressing the 3 domains of learning (cognitive, affective, and psychomotor). Descriptive statistics will be used to analyze the demographic, socioeconomic, and obstetric characteristics of the respondents. The analysis strategy follows the intention-to-treat principle. Logistic regression analysis will be used to compare the intervention with routine care on maternal pregnancy outcome and perinatal outcome. The recruitment of study participants began in May 2022 and will end in May 2023. Results include the effectiveness of the intervention in reducing the incidence of excessive gestational weight gain. We also will examine the maternal-fetal outcome as well as the barriers and facilitators that influence the weight gain of pregnant women. Data from this effectiveness trial will determine whether mami-educ successfully reduces rates of excessive weight gain during pregnancy. If successful, the findings of this study will generate knowledge to design and implement personalized prevention strategies for gestational obesity that can be included in routine primary care. ClinicalTrials.gov NCT05114174; https://clinicaltrials.gov/ct2/show/NCT05114174. DERR1-10.2196/44456.

Cost-effectiveness of social media advertising as a recruitment tool: A systematic review and meta-analysis.

Recruitment of study participants is challenging and can incur significant costs. Social media advertising is a promising method for recruiting clinical studies and may improve cost efficiency by targeting populations likely to match a study's qualifications. Prior systematic reviews of social media as a recruitment tool have been favourable, however, there are no meta-analyses of its cost-effectiveness. Studies evaluating recruitment costs through social media and non-social media methods were identified on MEDLINE and EMBASE. Articles were screened through a two-step process in accordance with PRISMA guidelines. Cost data were extracted from selected articles and meta-analyzed using the Mantel-Haenszel method. The primary outcome was the relative cost-effectiveness of social media compared to non-social media recruitment, defined as the odds ratio of recruiting a participant per US dollar spent. The secondary outcome was the cost-effectiveness of social media recruitment compared to other online recruitment methods only. In total, 23 studies were included in the meta-analysis. The odds ratio of recruiting a participant through social media advertising compared to non-social media methods per dollar spent was 1.97 [95% CI 1.24-3.00, P = 0.004]. The odds ratio of recruiting a participant through social media compared to other online methods only was 1.66 [95% CI 1.02-2.72, P = 0.04]. Social media advertising may be more cost-effective than other methods of recruitment, however, the magnitude of cost-effectiveness is highly variable between studies. There are limited data on newer social media platforms and on difficult-to-reach populations such as non-English speakers or older individuals.

Expected endpoints from future chikungunya vaccine trial sites informed by serological data and modeling.

In recent decades, there has been an increased interest in developing a vaccine for chikungunya. However, due to its unpredictable transmission, planning for a chikungunya vaccine trial is challenging. To inform decision making on the selection of sites for a vaccine efficacy trial, we developed a new framework for projecting the expected number of endpoint events at a given site. In this framework, we first accounted for population immunity using serological data collated from a systematic review and used it to estimate parameters related to the timing and size of past outbreaks, as predicted by an SIR transmission model. Then, we used that model to project the infection attack rate of a hypothetical future outbreak, in the event that one were to occur at the time of a future trial. This informed projections of how many endpoint events could be expected if a trial were to take place at that site. Our results suggest that some sites may have sufficient transmission potential and susceptibility to support future vaccine trials, in the event that an outbreak were to occur at those sites. In general, we conclude that sites that have experienced outbreaks within the past 10years may be poorer targets for chikungunya vaccine efficacy trials in the near future. Our framework also generates projections of the numbers of endpoint events by age, which could inform study participant recruitment efforts.

Social Media for Research Discourse, Dissemination, and Collaboration in Rheumatology.

Social media has become an important venue for rheumatologists, patients, organizations, and other stakeholders to discuss recent research advances in diagnosis and management of rheumatic disorders. In this article, we describe the current state of how social media may enhance dissemination, discourse, and collaboration in rheumatology research. Social media may refer to social platforms like Twitter and Instagram or digital media like podcasts and other websites that are operated for providing as free, open-access medical education (FOAM). Twitter has been one of the most active social media venues and continues to host a vibrant rheumatology community. Examples of research discussions on Twitter include organic user tweets, educational threads ("tweetorials"), live-tweeting academic conferences, and journals posting recently-accepted articles. Some research collaborations have been initiated through social media interactions. Social media may also directly contribute to research by facilitating the recruitment of study participants and the collection of survey-based data. Thus, social media is an evolving and important tool to enhance research discourse, dissemination, and collaboration in rheumatology.